BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI-FLOW MODEL 4000 PLUS

    MDR report key: 1170812 · Received September 15, 2008

    Report

    Report Number
    2921482-2008-00286
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 22, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K882594
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. THE PUMP WAS FOUND IN THE BIOMEDICAL ENGINEERING DEPARTMENT WITH AN UNSIGNED NOTE THAT STATED "THIS PUMP DOES NOT ALARM. RED LIGHT COMES ON BUT NO BEEP. THE VOLUME DIAL DOESN'T HELP." NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PUMP PROGRAMMING OR EVENTS DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI-FLOW MODEL 4000 PLUS 80-FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA